Status:
COMPLETED
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
Lead Sponsor:
Thallion Pharmaceuticals
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma
Detailed Description
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited. Each patient was to receive a treatment cycle consisting of CAP-232 via contin...
Eligibility Criteria
Inclusion
- Histologically confirmed stage IV kidney clear cell carcinoma.
- Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
- Measurable disease
- Age \>18 years.
- Life expectancy of greater than 3 months.
- At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
- ECOG performance status 2 or lower (Karnofsky 60%).
- Normal organ and marrow function
- Adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and have the willingness to sign a written informed consent document.
- Ability to receive central vein access catheter and manage an infusion pump.
- Women of child bearing potential must have a negative serum pregnancy test.
Exclusion
- Anti-cancer therapy within 4 weeks prior to entering the study
- Investigational agents less than 30 days prior to enrollment in the study.
- Known brain metastases
- History of allergic reactions attributed to compounds of similar composition to CAP-232.
- Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
- Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
- Breastfeeding
- Patients previously enrolled into this study and subsequently withdrawn
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00422786
Start Date
March 1 2007
End Date
March 1 2008
Last Update
July 15 2008
Active Locations (2)
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1
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, France, 34298
2
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France, 42270